An observational study in Critical Illness, Pain and Procedural Anxiety, sponsored by Sinop Atatürk State Hospital. Not yet recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-05.
Sponsored by Sinop Atatürk State Hospital · Observational
Bed bathing is a routine nursing procedure in the intensive care unit (ICU). In the study units, every patient routinely receives both a traditional bed bath with warm water and soap (every 10 days) and a bath with pre-packaged, disposable, no-rinse wipes (every 3 days). Little is known about how these two methods compare for pain, comfort and physiological stress in the same patient.
The goal of this randomized crossover trial is to compare the two bathing methods within the same adult ICU patients. The main question it aims to answer is: Does pain-related behavior during the bath, measured with the Critical-Care Pain Observation Tool (CPOT) while the patient is turned to the side, differ between the soap-and-water bath and the wipe bath? Other questions include whether the methods differ in vital signs and body temperature after the bath, anxiety, comfort, feeling of cleanliness, satisfaction and preference in patients who can self-report, bath duration, nursing time, cost, and adverse events.
The routine bathing schedule does not change. Only the order of each participant's first two study baths is decided by chance: either soap-and-water first and wipes 72 hours later, or wipes first and soap-and-water 72 hours later. Each patient serves as his or her own control. The first minute of the first lateral turn in both baths is video-recorded (face, upper body and arms only) and scored by an assessor who does not know which method was used.
Design: Single-center, prospective, randomized, two-period, two-sequence (wash-wipe / wipe-wash) crossover trial embedded in routine care, with blinded video-based assessment of the primary outcome. Setting: second-level (16 beds) and third-level (22 beds) adult ICUs, Sinop Atatürk State Hospital, Türkiye.
Routine care and schedule: All ICU patients routinely receive a whole-body soap-and-water bed bath every 10 days and a whole-body disposable wipe bath every 3 days. In the study, Session 1 is given within 24 hours after randomization with the method determined by the allocated sequence, and Session 2 is given with the other method 72 hours (±12 hours) later, which matches the routine 3-day interval. Thereafter, the routine schedule continues (soap-and-water every 10 days from the first wash; wipes every 3 days; if both fall on the same day, only the soap-and-water bath is given). Routine oral and perineal care continues. Additional baths are allowed when clinically needed.
Randomization: Sequences are allocated 1:1 using computer-generated lists with permuted blocks of 4 and 6, stratified by ICU level and communication status (Stratum A: able to self-report - RASS -1 to +1, CAM-ICU negative, able to use a visual analogue scale; Stratum B: unable to self-report). Allocation is concealed with sequentially numbered, opaque, sealed envelopes.
Interventions: Both methods cover the whole body in the same clean-to-dirty order with two lateral turns, two nurses, privacy measures, linen change and a standardized information script. Soap-and-water bath: warm water (43.5-46 °C), liquid soap, separate cloths and towels; each area is soaped, rinsed and towel-dried. Wipe bath: chlorhexidine-free, no-rinse disposable wipes warmed to ≤40 °C; a new wipe for each area, at least three passes with light pressure, air-dried.
Measurements: Full measurements are made in Sessions 1 and 2 at T0 (before the bath after ≥15 minutes of rest), during the bath, T1 (10 minutes after), T2 (30 minutes after) and during the 2 hours after the bath. CPOT and vital signs are recorded in all patients; Stratum A patients also rate anxiety (VAS-A), comfort, cleanliness and satisfaction, and state their preferred method after Session 2. For later routine baths, date, method, duration, materials and adverse events are recorded; skin is assessed at baseline, at each soap-and-water bath and at ICU discharge (descriptive only, because every patient receives both methods).
Blinding: The first minute of the first lateral turn in Sessions 1 and 2 is video-recorded with a hospital-owned, password-protected device (face, upper body and arms; ventilator screen in intubated patients; bathing materials and genital area excluded). Videos are coded without method or session information and scored in random order by an assessor not involved in bathing. The muscle tension item is taken from the in-room nurse. If no video is available, the in-room CPOT score is used. Videos are deleted after scoring.
Sample size: Assuming a clinically relevant within-patient difference of 1 CPOT point and a standard deviation of differences of 2.0 (dz = 0.5), two-sided alpha 0.05 and 80% power, 34 patients completing both sessions are required. Allowing about 15% loss before Session 2, 40 patients will be randomized.
Statistical analysis: Procedural CPOT will be analyzed with a linear mixed model including method, period, sequence and session-specific resting CPOT as fixed effects and patient as a random effect, adjusted for ICU level and stratum; all randomized patients contribute available data. Sensitivity analyses: Wilcoxon signed-rank test with Hodges-Lehmann estimate in completers, in-room scores, video-only sessions, adjustment for sedative infusions, and an ordinal mixed model. Secondary outcomes are analyzed with mixed models, McNemar tests or exact binomial test (preference), and interpreted as exploratory.
Safety: The bath is stopped if SpO2 \< 90% for >1 minute, MAP \< 65 mmHg or >20% fall, heart rate >130 or \<50/min or new arrhythmia, RASS ≥ +2, tube or catheter displacement, or at the patient's request.
10,054 studies on the registry are indexed under Pain; 1,649 are open to participants now.
This study's planned enrollment of 72 is below the median of 100 across 1,252 observational studies indexed under Pain.
Browse Pain studies →This is the only study on the registry with Sinop Atatürk State Hospital as lead sponsor.
Compared within Pain, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Critical Illness. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Age 18 years or older. Admitted to the second- or third-level adult ICU within the previous 48 hours and expected to stay at least another 24 hours
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Whole-body bed bath with warm water (43.5-46 °C) and liquid soap; each body area is soaped, rinsed and towel-dried; two lateral turns, two nurses. First bath within 24 hours after randomization, then every 10 days until ICU discharge.
Whole-body bed bath with pre-packaged, chlorhexidine-free, no-rinse disposable wipes warmed to ≤40 °C; a new wipe for each body area, no rinsing or towel-drying; two lateral turns, two nurses. Same schedule as the comparator arm.
Procedural pain behavior during the first lateral turn (CPOT)
Critical-Care Pain Observation Tool (CPOT) total score (range 0-8; higher scores indicate more pain-related behavior), scored from a video recording of the first minute of the first lateral turn by an assessor blinded to group allocation. Compared between groups adjusted for resting CPOT at T0.
Time frame: During the first study bath, at the first lateral turn (within 24 hours after randomization)
Proportion of patients with significant pain behavior during the bath
Proportion of patients with procedural CPOT score \> 2 (range 0-8) during the first lateral turn of the first study bath.
Time frame: During the first study bath (within 24 hours after randomization)
Post-bath CPOT score
CPOT total score (0-8; higher = more pain-related behavior), adjusted for resting CPOT.
Time frame: 10 and 30 minutes after the end of the first study bath
Anxiety in patients able to self-report
Visual analogue scale for anxiety (VAS-A; 0-10 cm; higher = more anxiety) in Stratum A patients, adjusted for the pre-bath score.
Time frame: 10 and 30 minutes after the end of the first study bath
Comfort, cleanliness and satisfaction in patients able to self-report
Numeric rating scales (0-10; higher = better) for comfort, feeling clean and fresh, and satisfaction with the bath, in Stratum A patients
Time frame: 10 minutes after the end of the first study bath
Plan to share: Undecided — De-identified individual participant data underlying the published results may be made available upon reasonable request to the principal investigator after publication, subject to approval by the ethics committee and in compliance with Turkish Personal Data Protection Law No. 6698. Video recordings will not be shared and will be deleted after scoring.
Start is estimated for Nov 2026; primary completion for Feb 2027, 3 months later.
Of 504 non-industry observational studies under Pain, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 42. This study's planned 3 months is below that.
Counting every sponsor, half of 519 studies reached it within 18 months; a quarter within 8 and three quarters within 41.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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